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Soluble tablet containing clopidogrel

A clopidogrel and soluble tablet technology, applied in the directions of medical preparations containing active ingredients, pill delivery, medical preparations without active ingredients, etc., can solve the problem of slow disintegration and dissolution of preparations, low bioavailability, and slow onset of action. and other problems to achieve the effect of improving compliance, convenient storage and carrying

Inactive Publication Date: 2009-12-16
SHENZHEN NEPTUNUS PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to provide a clopidogrel-containing soluble tablet, which solves the problems of slow disintegration and dissolution, slow onset and low bioavailability of existing preparations

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1 Preparation of soluble tablets containing clopidogrel

[0023] Component dosage (g)

[0024] Clopidogrel Bisulfate 100

[0025] Mannitol 100

[0026] Sodium croscarmellose starch 11.0

[0027] Polyethylene glycol 6000 9.0

[0028]

[0029] 1000 pieces

[0030] Preparation method: pass clopidogrel bisulfate, mannitol, and croscarmellose sodium through a 100-mesh sieve respectively, then place all the components in a mixer to mix well, and directly compress the tablets.

[0031] All indicators of the obtained tablets were in compliance with the pharmacopoeia regulations. According to the aforementioned inspection method, the disintegration time limit was qualified, and the disintegration and melting time was 146 seconds.

Embodiment 2

[0032] Example 2 Preparation of soluble tablets containing clopidogrel

[0033] Component dosage (g)

[0034] Clopidogrel Bisulfate 100

[0035] Lactose 1000

[0036] Croscarmellose Sodium 25.0

[0037] Sodium chloride 15.0

[0038]

[0039] 1000 pieces

[0040] Preparation method: pass clopidogrel bisulfate, lactose, and low-substituted hydroxypropyl cellulose through a 100-mesh sieve, and then place them in a mixer to mix well, and use 5% lactose aqueous solution to make soft materials with moderate hardness. Granulate with a 24-mesh sieve, dry at 40-45°C, finish with a 20-mesh sieve, add sodium chloride and mix well, and then press the tablet.

[0041] All indicators of the obtained tablets were in compliance with the pharmacopoeia regulations. According to the aforementioned inspection method, the disintegration and dissolution time limit was qualified, and the disintegration time was 113 seconds.

Embodiment 3

[0042] Example 3 Preparation of soluble tablets containing clopidogrel

[0043] Component dosage (g)

[0044] Clopidogrel Bisulfate 100

[0045] Mannitol 200

[0046] Low-substituted hydroxypropyl cellulose 15.0

[0047] Sodium chloride 5.0

[0048]

[0049] Polyethylene glycol 6000 10.0

[0050]

[0051] 1000 pieces

[0052] Preparation method: pass clopidogrel hydrogen sulfate, mannitol, and low-substituted hydroxypropyl cellulose through 100 sieves respectively, then place all the components in a mixer to mix well, adjust the tablet weight, and directly compress the tablets to obtain.

[0053]All indicators of the obtained tablets were in compliance with the pharmacopoeia regulations. According to the aforementioned inspection method, the disintegration and melting time limit was qualified, and the disintegration time was 91 seconds.

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PUM

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Abstract

The invention discloses a clopidogrel soluble tablet and a preparation method thereof. The soluble tablet contains an active ingredient of clopidogrel or pharmaceutically acceptable salts and pharmaceutical excipients, wherein the pharmaceutical excipients comprise soluble excipients. The ratio of the clopidogrel to the soluble excipients is 1:1-10 in percentage by weight. The soluble tablet can also contain a disintegrant and a lubricant. The preparation method for the clopidogrel soluble tablet can be a direct tabletting method or a wet granulation tabletting method. Compared with a common tablet, the clopidogrel soluble tablet has the advantages of fast disintegration and formation of solution state in water within a short period of time, is easy in storage and use and particularly convenient for a patient with swallowing difficulty, and significantly improves the compliance of the patient.

Description

Technical field [0001] The invention relates to a medicine for cardiovascular and cerebrovascular diseases, in particular to a soluble tablet containing clopidogrel and a preparation method thereof. Background technique [0002] With the aging of society and the improvement of living standards, the incidence and mortality of cardiovascular and cerebrovascular diseases are increasing day by day. According to a recent study, surveys in 8 major regions of the world, including developed and developing countries, show that ischemic heart disease and cerebrovascular disease have become the main causes of death. For example, in the United States, cardiovascular disease far exceeds cancer, accounting for 42% of all deaths, becoming the main cause of death. In my country, cardiovascular and cerebrovascular diseases have also become one of the common and frequently-occurring diseases of the elderly, especially cerebrovascular diseases, with a prevalence rate of up to 491.8 per 100,000 peop...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4365A61K47/38A61K47/32A61K47/34A61K47/36A61P9/10A61P7/02A61K47/10
Inventor 叶冠豪王志国冯汉林李勇朱丹
Owner SHENZHEN NEPTUNUS PHARM CO LTD
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